Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

• ClinicalTrials.gov Identifier: NCT02278640
• Recruitment Status: Completed
• First Posted: October 30, 2014
• Results First Posted: August 19, 2016
• Last Update Posted: August 19, 2016
• Sponsor: Ethicon Endo-Surgery
• Information provided by (Responsible Party): Ethicon Endo-Surgery

Study Description

Brief Summary:

This is a prospective, non-randomized, single arm, multicenter, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. The study will not modify or influence current surgeon technique. Investigators will perform each procedure using the device in compliance with their standard surgical approach and product labeling.

The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines

Condition or disease	Intervention/treatment	Phase
Benign Disease Where Total Hysterectomy is Indicated	Device: Harmonic ACE®+7 Shears	Phase 4

Detailed Description:

Study Population: Subjects enrolled into this study will undergo elective total laparoscopic hysterectomy for benign indications wherein dissection and transection of the uterine vasculature is indicated.

Primary Variables: Percentage of subjects achieving hemostasis at the named vessel/pedicle (UA or UP) on the left side. Percentage of subjects achieving hemostasis at the named vessel/pedicle (UA or UP) on the right side.

Definition: Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device.

Note: Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.

Secondary Endpoints:

Percentage of subjects achieving hemostasis at the OP on the left and/or right side.

If the study procedure also includes the transection and sealing of one or both OPs, hemostasis of the left and/or right OP will also be recorded. Hemostasis of the OP is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the ovarian vasculature (left and/or right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.).

Note: Multiple applications of the Advanced Hemostasis mode or the device in a MAX or MIN mode are allowed.

Exploratory endpoints include:

Requirement for additional measures to obtain hemostasis on the named vessel/pedicle (UA or UP and/or OP) on the left and right side Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if "yes", the name and type, time of application (24 hour clock).

Use of additional hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded as yes or no; if "yes", the name and type, number/volume, and time of application (24 hour clock).

Complications associated with vaginal cuff healing including dehiscence or separation, infection, cellulitis, abscess, inflammation, and granulation associated with each suture used as part of the study.

Adverse events attributed to the study device or procedure will be collected from time of surgery to Visit 4 (Approximately 4 to 6 weeks after study surgery or as per standard of care (SOC)).

No formal sample size determination is required for this study. Approximately 40 subjects from the United States and the European Union are planned to be enrolled into this study.

Global indication for use of the The Harmonic ACE®+7, 5mm Diameter Shears with Advanced Hemostasis:

Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7mm in diameter, using the Advanced Hemostasis function.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
• Study Start Date: October 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Harmonic ACE®+7 Shears; Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy	Device: Harmonic ACE®+7 Shears; Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. [ Time Frame: Intraoperative ]
   Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.
2. Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side. [ Time Frame: Intraoperative ]
   Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.

Secondary Outcome Measures :

1. Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side. [ Time Frame: Intraoperative ]
   Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.
2. Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side. [ Time Frame: Intraoperative ]
   Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Subjects satisfying all of the following criteria will be considered the screening population and will be eligible for participation in this study:

1. Indicated for elective total laparoscopic hysterectomy
2. Age >=40 years and no future desire for fertility

Exclusion Criteria:

Subjects with any of the following criteria will be excluded from the study:

Preoperative exclusion criteria:

1. Known or suspected uncontrolled bleeding disorders
2. Subjects unlikely to comply with protocol procedures or adhere to the study visit schedule
3. Any condition rendering a subject unable to understand the nature, scope, and possible consequences of the study or study procedures
4. Any Subject unwilling to sign the study informed consent document
5. Any suspected malignancy

6. Any Subject of childbearing potential with a positive or serum pregnancy test within 24 hours prior to surgery

   Intra-operative exclusion criteria:

7. Any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure

Contacts and Locations

Locations

United States, Florida

Florida Hospital Celebration Health

Celebration, Florida, United States, 34747

United States, Illinois

The Advanced Gynecological Surgery Institute

Schaumburg, Illinois, United States, 60173

Netherlands

Gynaecoloog (aandachtsgebied: endoscopische chirurgie)

Nijmegen, Netherlands

United Kingdom

The Royal Surrey County Hospital NHS Trust

Surrey, United Kingdom

Sponsors and Collaborators

Ethicon Endo-Surgery

More Information

Publications:

Nieboer TE, Steller CJ, Hinoul P, Maxson AJ, Schwiers ML, Miller CE, Coppus SF, Kent AS. Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:135-9. doi: 10.1016/j.ejogrb.2016.03.035. Epub 2016 Apr 14.

• Responsible Party: Ethicon Endo-Surgery
• ClinicalTrials.gov Identifier: NCT02278640
• Other Study ID Numbers: ENG-14-002
• First Posted: October 30, 2014
• Results First Posted: August 19, 2016
• Last Update Posted: August 19, 2016
• Last Verified: July 2016